Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-09-23

Brief Summary

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Randomized double blind placebo controlled pilot study/proof of concept-study to see if intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis suppurativa

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Detailed Description

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Twenty patients with hidradenitis suppurativa will be enrolled and randomised to treatment with either botulinum toxin B or placebo (saline) in affected areas.

Intervention and recording of data will be performed every three months. After three months, all patients will receive active substance. After six months, randomization will revealed. Patients with clinical improvement will be given the opportunity to continue treatment for additional six months.

Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

First treatment - one placebo and one active substance group Thereafter - all patients receive active substance

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.

Study Groups

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Botulinum B Toxin

Botulinum toxin B (Neurobloc(R)) 50 Units (U)/ml 0,05-0,1 ml/injection intradermally in a grid with 1- 1 1/2 cm between every injection in affected areas A maximum of 4000 U/patient/treatment Treatment every three months

Group Type EXPERIMENTAL

Botulinum B Toxin

Intervention Type DRUG

Intradermal injections

Placebo

Saline (NaCl 0,9%) 0,05-0,1 ml/injection intradermally in a grid With 1- 1 1/2 cm between every injection in affected areas Treatment in placebo group (n=10) only at first intervention

Group Type PLACEBO_COMPARATOR

Placebo Saline

Intervention Type OTHER

Intradermal injections

Interventions

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Botulinum B Toxin

Intradermal injections

Intervention Type DRUG

Placebo Saline

Intradermal injections

Intervention Type OTHER

Other Intervention Names

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Neurobloc Saline (NaCl 0,9%)

Eligibility Criteria

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Inclusion Criteria

* Patients with active hidradenitis in the stage I-III according to Hurleys classification. Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention. Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area

Exclusion Criteria

* Patients in need of emergency medical or surgical treatment of hidradenitis will be excluded until the disease is in a quiet, controlled phase.

Pregnant or lactating, as well as patients with neurological disease such as myasthenia gravis or motor neuron disease.

Eligible Sex

ALL

Accepts Healthy Volunteers

No